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  • Sr NPI Manufacturing Engineer

    J&J Family of Companies (Santa Clara, CA)



    Apply Now

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

    Job Function:

    Supply Chain Engineering

    Job Sub** **Function:

    Manufacturing Engineering

    Job Category:

    Scientific/Technology

    All Job Posting Locations:

    Santa Clara, California, United States of America

    Job Description:

    About MedTech

     

    Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

     

    Your unique talents will help patients on their journey to wellness. Learn more at** **https://www.jnj.com/medtech

     

    We are searching for the best talent for a Sr NPI Manufacturing Engineer to be in Santa Clara, CA.

    Purpose:

    The Senior Manufacturing Engineer, NPI is an individual with:

    High drive and urgency to launch quality products to market

     

    High drive to innovate through continuous improvement throughout the product’s life cycle.

     

    Highly collaborative; works with Supply Chain and R&D Teams, Technicians, Quality, and peers to develop a world-class manufacturing process for Medical Robotic Capital Systems

     

    Strong determination, ability, and excitement leading and developing, documenting and qualifying test processes used during the manufacturing of electro-mechanical components and subassemblies

     

    Experience in making process improvements that yield both a profitable and reliable product

    Clear communication when providing feedback on Design For Assembly, COGS, Manufacturability, Quality, etc,

    A positive take on challenging the status quo to drive process excellence, while understanding the “why” in design intent, patient safety and overall product functionality

     

    Eagerness to engage in hands-on activities, comprehending system interactions, and automating repetitive tasks

     

    Aptitude for quickly formulating action plans and executing them effectively to address challenges

     

    Demonstrated resilience, proactivity, and a positive mindset when facing challenging circumstances

     

    Vision to develop and undertake projects that can handle the complexities in scaling up a robotic system in future advanced manufacturing methods

    You will be responsible for:

    Robotics & Digital Solutions** **, part of the Johnson & Johnson family of companies, is recruiting for a NPI Senior Manufacturing Engineer, located in Santa Clara, CA.** **Robotics & Digital Solutions** **is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to** **revolutionizing surgery with minimally invasive procedures** **. Our continuing dedication to** **Shape the Future of Surgery** **is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit** **www.ethicon.com** **.

    The** **Senior Manufacturing Engineer, NPI** **is an individual with:

    High drive and urgency to launch quality products to market

     

    High drive to innovate through continuous improvement throughout the product’s life cycle.

     

    Highly collaborative; works with Supply Chain and R&D Teams, Technicians, Quality, and peers to develop a world-class manufacturing process for Medical Robotic Capital Systems

     

    Strong determination, ability, and excitement leading and developing, documenting and qualifying test processes used during the manufacturing of electro-mechanical components and subassemblies

     

    Experience in making process improvements that yield both a profitable and reliable product

    Clear communication when providing feedback on Design For Assembly, COGS, Manufacturability, Quality, etc,

    A positive take on challenging the status quo to drive process excellence, while understanding the “why” in design intent, patient safety and overall product functionality

     

    Eagerness to engage in hands-on activities, comprehending system interactions, and automating repetitive tasks

     

    Aptitude for quickly formulating action plans and executing them effectively to address challenges

     

    Demonstrated resilience, proactivity, and a positive mindset when facing challenging circumstances

     

    Vision to develop and undertake projects that can handle the complexities in scaling up a robotic system in future advanced manufacturing methods

    The Senior Manufacturing Engineer, NPI will Lead Manufacturing and Process development activities across the organization and functional groups with responsibilities in the areas focus areas:

    General Engineering and Leadership

     

    Strong leadership capabilities to mentor, coach and develop various experience level Manufacturing Engineer, NPI teams

     

    Collaborates, coaches and supports design teams to develop and introduce manufacturing processes that scale to commercialization.

     

    Thoroughly documents procedures and results to ensure traceability and promote knowledge sharing among team members

     

    Technical leader and driver on owned projects; serve as a technical resource to other engineering groups and project leaders

     

    Process Engineering

     

    Develops new and or improved processes through the application of theoretical and practical engineering

     

    Designs and develops technically complex processes to improve quality and efficiency.

     

    Utilizes statistical tools (such as GR&R, SPC and Cp/Cpk) to ensure processes/fixtures are scalable and are continuing to perform properly once qualified

     

    Analyses and evaluates all meaningful technical trends and developments and incorporates them in appropriate assignments

     

    Responsible for data analysis reports to communicate machine capability to cross-functional teams

     

    Plans, defines, and implements continuous process improvements to existing manufacturing operations including process verification, MFG documentation updates and process validation

     

    Designs, documents, assembles, qualifies, and releases custom, off-the-shelf manufacturing and testing tooling, fixtures, and equipment, including maintenance plans and calibrations.

     

    Product Engineering

     

    Component and manufacturing assembly development with a strong focus on DFx methodologies (Design for Manufacturability/Assembly/Cost/Quality/x)

     

    Provides early and ongoing manufacturing involvement to ensure new products are mechanically manufacturable

     

    Capable in understanding and building Tolerance Analysis of parts and assemblies

     

    Releases engineering documentation and Bill of Materials

     

    Provides direction and mentorship to third party machine/automation suppliers and/or CM’s

     

    Failure/Data analysis and Troubleshooting

     

    Develops Manufacturing and Test Processes with cross-functional teams

     

    Leads Corrective and Preventative Action plans by providing solutions using independent thinking and problem-solving skills including FMEAS, Fishbone, 5 Whys or Pareto Charts.

     

    Leads troubleshooting/root cause investigations and resolves manufacturing production issues following GMP and the companies Quality Management System.

     

    Genuine curiosity to comprehend the functioning and troubleshooting of systems, coupled with a proven ability to identify and resolve technical issues efficiently

    Qualifications / Requirements:

    Education Requirements:

    A minimum of a Bachelor's or equivalent University Degree is required with a primary focus in Mechanical, Manufacturing/Industrial, Electrical engineering, or related field is required, Mechatronics Engineering degree preferred. Master’s or advanced degree preferred.

    Experience Requirements:

    Proficiency in reading engineering drawings and electrical schematics

     

    Proficiency with GD&T Methodologies

     

    Proficient in SolidWorks and PDM

    Proficient in performing system/electrical debug using instrumentation such as:

    oscilloscopes, DMMs, multi-meters, other advanced test instruments

     

    Capable of communicating complex technical problems to a wide audience of experience

     

    Versed and experienced in Good Engineering Practices (GEP) and Good Manufacturing Practices (GMP).

     

    Able to make models, first principle calculations and simulations to solve technical problems

    Strong understanding and experience executing on:

    Manufacturing equipment design and development

     

    Process validation planning/execution, IQ/OQ/PQ protocols and reports

     

    Regulated industries component and manufacturing qualification processes

     

    Using Statistical Methods for Manufacturing Process Capability and Control (SPC and Cp/Cpk)

     

    Measurement System Analyses (MSA) and Gage R&R and Compatibility

     

    Risk-based manufacturing documentation, including process and component FMEAs

     

    Crafting machine qualification requirements, design of experiments and failure analysis

     

    COGS Analysis

     

    DFx Methodologies

     

    Prior experience in medical device, working in regulated environment in compliance to ISO 13485 and 21 CFR 820.

     

    Understands machine qualification including calibration, correlation, capability, repeatability, and reproducibility

     

    Knowledge of a broad range of component manufacturing methods/processes (Metals/Plastics/Electro-Mechanical)

     

    Experience with risk-based manufacturing documentation, including process, component, and supplier FMEAs.

    Preferred:

    Experience with robotics or large capital equipment assembly

     

    Strong understanding of robotic systems encompassing hardware, software, and firmware components

     

    Familiarity with various sensors and their integration

     

    Experience in automation equipment used for alignment, assembly and/or measurement of components.

     

    Conducts research and analysis to identify state-of-the-art technologies, algorithms, and equipment for testing robotic systems and subsystems

     

    Creates customized test applications to enhance the efficiency, modularity, and repeatability of system validation processes

     

    Agile PLM and MES experience

     

    Experience with Composer SW

     

    Experience working with JIRA, and Scrum Project Management Methodology

     

    Six-Sigma and Lean Manufacturing Certification

     

    Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands is highly preferred

    Other:

    Ability to travel (10%) to and from headquarters in Santa Clara, CA At Johnson & Johnson, where we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce.

     

    _Additional Information:_

     

    The anticipated base pay range for this position is $105,000 to $169,050.

     

    The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

     

    Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

     

    Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

     

    This position is eligible to participate in the Company’s long-term incentive program.

    Employees are eligible for the following time off benefits:

    Vacation – up to 120 hours per calendar year

     

    Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

     

    Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

     

    Additional information can be found through the link below.** **https://www.careers.jnj.com/employee-benefits

     

    The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

     

    The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

     

    Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

     

    Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center** **([email protected]) or contact AskGS to be directed to your accommodation resource

    Required Skills:

    Preferred Skills:

    Accelerating, Coaching, Critical Thinking, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Performance Measurement, Product Design, Program Management, Project Engineering, Project Scheduling, Risk Compliance, Robotic Automation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

    The anticipated base pay range for this position is :

    The anticipated base pay range for this position is $105,000 to $169,050.

    Additional Description for Pay Transparency:



    Apply Now



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